Alnylam Reports Fourth Quarter and Full Year 2020 Financials

 − Achieved Fourth Quarter and Full Year 2020 Global Net Product Revenues of $113 Million and $362 Million, Respectively –

− Achieved Regulatory Approvals of OXLUMO™ in the EU and U.S. and Leqvio®, by Partner Novartis, in the EU –

– Launched “Alnylam P⁵x25” Strategy for Planned Transition to a Top Five Biotech in Market Capitalization Over the Next Five Years –

– Reported Positive Topline Results from HELIOS-A Phase 3 Study of Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy –

– Provides 2021 Combined Net Product Revenue Guidance of $610-660 Million, in addition to Collaboration & Royalty Revenue and Operating Expense Guidance –

https://www.biospace.com/article/releases/alnylam-pharmaceuticals-reports-fourth-quarter-and-full-year-2020-financial-results-and-highlights-recent-period-activity/

AC Immune Alzheimer’s Vax Has Potent Antibody Response in Phase 1b/2a Study

 Interim results of ACI-35.030 vaccination show high titers of antigen-specific antibodies at potentially therapeutic levels in 100% of older patients with early Alzheimer’s disease

ACI-35.030 was safe and well tolerated with no safety concerns observed. Results support plans to further develop the Alzheimer’s vaccine into Phase 2/3

AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced positive interim results from its ongoing Phase 1b/2a clinical trial evaluating its first-in-class anti-phospho-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease (AD). ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early AD, achieving antibody levels several orders of magnitude higher than pre-vaccination levels. No clinically relevant adverse events were observed. AC Immune and strategic partner Janssen Pharmaceuticals, Inc., believe these interim findings from the first two dosing groups support plans to advance the development of ACI-35.030 for the treatment of AD.

Immunization with anti-Tau vaccines represents a novel strategy for the treatment of AD and other neurodegenerative diseases characterized by Tau pathology. ACI-35.030 is a first-in-class vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. Anti-pTau antibodies generated by ACI-35.030 have the potential to reduce the spread and seeding of Tau pathology, which is a major hallmark of AD.

These new results provide encouraging clinical support for ACI-35.030, which employs a new vaccine formulation to achieve active immunization that significantly improves antibody responses in older patients with potentially attenuated immune systems. Notably, anti-pTau vaccination generates antibody responses with pharmacokinetic characteristics and target epitopes that differ substantially from the Company’s anti-Tau monoclonal antibody semorinemab, highlighting the comprehensive and complementary nature of AC Immune’s anti-Tau pipeline.

https://finance.yahoo.com/news/ac-immune-alzheimer-vaccine-generates-120000552.html

AstraZeneca expects COVID-19 vaccine capacity of 200M a month by April

 AstraZeneca expects to produce more than 100 million doses of its COVID-19 vaccine - developed with Oxford University - this month, ramping up to more than 200 million a month by April, Chief Executive Pascal Soriot said on Thursday.

Mene Pangalos, head of BioPharmaceuticals R&D at the British drugmaker earlier said the company expects much-anticipated data for the late-stage U.S. trial of its vaccine before the end of March.

A read-out on data is “only weeks away”, he said on a media call after release of the company’s 2020 results.

https://www.reuters.com/article/us-astrazeneca-results-vaccine/astrazeneca-expects-covid-19-vaccine-capacity-of-200-million-a-month-by-april-idUSKBN2AB117

EU close to sealing supply deal with Novavax for COVID-19 vaccines

 The European Union could sign a supply deal with Novavax this week or next for the U.S. company’s COVID-19 vaccine candidate, two EU officials involved in the talks with the firm said.

The EU concluded in December preliminary negotiations with Novavax for the supply of 100 million doses and an option for another 100 million.

“Talks with Novavax have intensified and we aim to agree the contract this week or next,” one EU official said.

A second EU official, involved in talks, confirmed that possible timetable for a deal, but added that discussions with the company’s lawyers were still underway, declining to elaborate on what were the outstanding issues.

Last week Europe’s drug regulator said it had launched a real-time review of Novavax’s vaccine to speed up potential approvals.

The vaccine is still being trialled, but preliminary data showed the vaccine was 89.3% effective in preventing COVID-19 in a trial conducted in the United Kingdom, and was nearly as effective in protecting against the more highly contagious variant first discovered in the UK.

The possible deal with Novavax would be the seventh sealed by the EU with vaccine makers for the supply of COVID-19 shots. It already has agreements with AstraZeneca, Johnson & Johnson, Pfizer-BioNTech, CureVac, Moderna and Sanofi-GSK for a total of about 2.3 billion doses.

https://www.reuters.com/article/us-health-coronavirus-eu-novavax/eu-close-to-sealing-supply-deal-with-novavax-for-covid-19-vaccines-sources-idUSKBN2AB10H

CDC to issue new COVID-19 guidelines for schools on Friday: White House

 The federal Centers for Disease Control and Prevention plans to issue new guidelines for U.S. schools reopening on Friday, White House coronavirus adviser Andy Slavitt said.

Reopening schools is a top priority for the administration of President Joe Biden, who has stressed he wants it done safely and has supported vaccinations for teachers.

The top U.S. health safety agency has been working on a new set of guidelines to meet the challenges that school districts face across the country.

“Tomorrow, the CDC is going to roll out their operating plan to give school districts, local communities, the guidance they need to know to begin to do that and to begin to do that aggressively,” Slavitt said on Thursday.

Pressure to reopen or expand in-person learning for students has been building across the United States in recent weeks as the impact of remote learning on education and family life has become more apparent. The debate over how and when to safely reopen has become heated in many school districts.

Slavitt said he understood why some parents were impatient to reopen and stressed that the CDC was being very thorough in formulating its guidelines on masking, social distancing and other issues.

“I can assure you of one thing: There’s no debate over whether to open schools here. There’s a debate over how,” Slavitt said. “And if it were as simple as ‘open all the schools,’ they’d all be open by now.”

https://www.reuters.com/article/us-health-coronavirus-usa-schools/cdc-to-issue-new-school-covid-guidelines-friday-white-house-idUSKBN2AB1HS

Vaccinated people need not quarantine post COVID-19 exposure: CDC

 People who have received the full course of COVID-19 vaccines can skip the standard 14-day quarantine after exposure to someone with the infection as long as they remain asymptomatic, U.S. public health officials advised.

The U.S. Centers for Disease Control and Prevention (CDC) said on Wednesday the vaccines have been shown to prevent symptomatic COVID-19, thought to play a greater role in the transmission of the virus than asymptomatic disease.

“Individual and societal benefits of avoiding unnecessary quarantine may outweigh the potential but unknown risk of transmission (among vaccinated individuals),” the CDC said.

The agency has laid down strict criteria for people who would no longer have to quarantine after the vaccinations, including having received both doses of a two-dose vaccine.

People who choose not to quarantine should do so only if they received their last dose within three months, and should only avoid 14 days quarantine after their last shot, the time it takes to develop immunity, CDC said.

Fully vaccinated persons who do not quarantine should still watch for symptoms for 14 days following an exposure.

Two-dose vaccines from Pfizer Inc and Moderna Inc have been authorized for emergency use in the United States. Johnson & Johnson applied for a U.S. authorization of its single-dose shot last week.

https://www.reuters.com/article/us-health-coronavirus-cdc-quarantine/vaccinated-people-need-not-quarantine-post-covid-19-exposure-cdc-says-idUSKBN2AB0EG

U.S. Diagnostics Firm GenMark Explores Sale Amid Interest

 GenMark Diagnostics Inc. is exploring a sale after the U.S. firm was approached by potential buyers, according to people familiar with the matter.

GenMark is working with a financial adviser as it fields interest from other medical diagnostics companies, the people said, asking not to be identified because the deliberations are private.

Shares in GenMark have climbed more than 15% this year, giving the company a market value of about $1.2 billion.

Deliberations are at an early stage and the company could still decide against a sale, the people said. A representative for Carlsbad, California-based GenMark declined to comment.

GenMark competes with companies including Hologic Inc. and Quidel Corp. in the booming medical testing industry. It makes molecular diagnostic equipment to help detect infectious diseases including respiratory pathogens, and for blood culture identification.

The company’s respiratory pathogen panels help identify the most common viral and bacterial organisms linked to upper respiratory infections, including the virus that causes Covid-19, according to its website. GenMark said last month it expects to report revenue of about $171 million for 2020, a 95% increase over the previous year.

Fidelity Investments, BlackRock Inc. and Vanguard Group are among its top shareholders, according to data compiled by Bloomberg.

A sale of GenMark could add to a wave of dealmaking activity among diagnostics companies, which have benefitted from the surge in demand for Covid-19 testing. Quidel is weighing a combination with Qiagen NV, Bloomberg News reported this week. Last month, Thermo Fisher Scientific Inc. agreed to acquire Mesa Biotech, a privately-held molecular diagnostic company, for about $450 million in cash.

https://www.bloomberg.com/news/articles/2021-02-11/u-s-diagnostics-firm-genmark-said-to-explore-sale-amid-interest